AbnormalityNCT01105676
Vascular Malformations and Abnormalities of Growth
A study testing skin biopsy in people with Abnormality, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
To take part in this study you/your child have a vascular malformation, a type of blood vessel disorder whose cause is unknown. The investigators will do this by looking at changes in the genes and proteins in the cells of the malformation as well as normal cells. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Abnormality
- What is being tested?
- skin biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Greater than 1 year of age
- Diagnosis of vascular malformation
- Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation given they have the cognitive capacity to do so.
Who cannot join
- Patients less than 1 year of age
- Vascular malformations likely to result in poor wound healing or located in areas of the body prone to significant scarring
- Individuals with vascular malformations and previous diagnosis of disseminated intravascular coagulopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
To take part in this study you/your child have a vascular malformation, a type of blood vessel disorder whose cause is unknown.
The investigators will do this by looking at changes in the genes and proteins in the cells of the malformation as well as normal cells.
The investigators are doing this research because currently there is no known cause of vascular malformations and no way to know whether or not other health problems will occur in addition to the malformation. Through this research we hope to create standard methods for doctors to examine and treat people with vascular anomalies.
Read the detailed description
If you/your child agree to participate
- Informed consent and permission to use or disclose you/your child's health information for reserve purposes will be obtained by the research team. You will receive a copy of the consent form.
- You/your child will be examined by a physician from the research team and interviewed about your medical background and condition every year for five years.
- You/your child will have photographs taken of the affected area at each visit.
- You/your child will have two, one time biopsies or skin samples taken by a dermatologist. Skin areas will be numbed with lidocaine and a 4 or 5 millimeter (or approximately 0.15 to 0.19 inch) sample will be taken in two different locations. The dermatologist taking the skin sample will use every effort to choose an area that can be covered by clothing or kept out of sight to others. The doctor will either use gelfoam or one stitch/suture per biopsy to seal off the area, which helps with healing and preventing bleeding. If a stitch is placed in the biopsy site, another visit about 7-10 days following the procedure will be necessary to remove the stitch.
- You may still participate in the study if you consent to having only one biopsy taken of your affected (lesion) skin and not one of your unaffected (normal) skin.
- Conditions
- Abnormality
- Being tested
- skin biopsy
- Keywords
- vascular malformation, vascular anomalies, abnormalities of growth, overgrowth, subjects with vascular malformations abnormalities of growth.
- Medical subject headings
- Congenital Abnormalities, Vascular Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyProcedure or surgery
Two skin biopsies will be taken one time
| Study group | Role | What they receive |
|---|---|---|
| single group single arm study | Experimental | Open no masking is used. All involved know the identity of the intervention assignment Receives: Procedure: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of growth over time
Measured: 5 years
Secondary outcomes (1)
Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startNov 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbnormalityStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's National Research Institute
- Responsible party
- Principal investigator, Beth Drolet, Medical College of Wisconsin
- Investigators
- Kelly Duffy, MD, Principal investigator, Children's Hospital and Health System Foundation, Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105676
- Sponsor's protocol ID
- CHW 08/204, GC 821
- Status last verified
- Jan 2014
- First submitted
- 15 Apr 2010
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Malformations and Abnormalities of Growth
- ClinicalTrials.gov ID
- NCT01105676
- Acronym / sponsor ID
- CHW 08/204, GC 821
- Conditions
- Abnormality
- Keywords
- vascular malformation, vascular anomalies, abnormalities of growth, overgrowth, subjects with vascular malformations abnormalities of growth.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's National Research Institute
- Study start
- Nov 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To take part in this study you/your child have a vascular malformation, a type of blood vessel disorder whose cause is unknown.
The investigators will do this by looking at changes in the genes and proteins in the cells of the malformation as well as normal cells.
The investigators are doing this research because currently there is no known cause of vascular malformations and no way to know whether or not other health problems will occur in addition to the malformation. Through this research we hope to create standard methods for doctors to examine and treat people with vascular anomalies.
Detailed description
If you/your child agree to participate
- Informed consent and permission to use or disclose you/your child's health information for reserve purposes will be obtained by the research team. You will receive a copy of the consent form.
- You/your child will be examined by a physician from the research team and interviewed about your medical background and condition every year for five years.
- You/your child will have photographs taken of the affected area at each visit.
- You/your child will have two, one time biopsies or skin samples taken by a dermatologist. Skin areas will be numbed with lidocaine and a 4 or 5 millimeter (or approximately 0.15 to 0.19 inch) sample will be taken in two different locations. The dermatologist taking the skin sample will use every effort to choose an area that can be covered by clothing or kept out of sight to others. The doctor will either use gelfoam or one stitch/suture per biopsy to seal off the area, which helps with healing and preventing bleeding. If a stitch is placed in the biopsy site, another visit about 7-10 days following the procedure will be necessary to remove the stitch.
- You may still participate in the study if you consent to having only one biopsy taken of your affected (lesion) skin and not one of your unaffected (normal) skin.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group single arm study | Experimental | Procedure: skin biopsyOpen no masking is used. All involved know the identity of the intervention assignment |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Greater than 1 year of age
- Diagnosis of vascular malformation
- Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation given they have the cognitive capacity to do so.
Key exclusion criteria (3 listed)
- Patients less than 1 year of age
- Vascular malformations likely to result in poor wound healing or located in areas of the body prone to significant scarring
- Individuals with vascular malformations and previous diagnosis of disseminated intravascular coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin biopsyTwo skin biopsies will be taken one time | Procedure or surgery | single group single arm study |
Primary outcome
Percent of growth over time
Time frame: 5 years
1 secondary outcome
Patient specific gene and protein expression levels that can distinguish affected from unaffected tissue in patients.
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Duffy, MD principal investigator
Children's Hospital and Health System Foundation, Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy in people with Abnormality, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of growth over time (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2014.